The FSMA and the Preventive Controls Rule intends to give U.S. Food and Drug Administration (FDA) the authority to require that companies build food safety preventative controls into their processes, including verification. The intent is to predict and avoid some inherent risks in food production.
There are five aspects of verification that are proposed by FDA (§117.150). All five should be noted in the food safety plan, along with appropriate details on how each is accomplished. As proposed by FDA, the five components of verification are: Validation, Verifying that Monitoring is Occurring, Verifying that Corrective Actions are Occurring, Verification of Implementation and Effectiveness of Preventive Controls, and Reanalysis.
Here’s a pie factory example of how verification processes are being implemented to ensure foreign materials are being controlled.
In this scenario the product is a blackberry cobbler packaged in an aluminum tin. The qualified individual determined during the hazard analysis that rocks are an inherent risk in blackberries as a physical hazard that is significant. Because the cobbler is packaged in an aluminum tin, the preventive control is X-ray detection.
During a production day, there were multiple rejects of the blackberry cobbler by the X-ray system. Would this require corrective action? At this point based on the preventive control, it seems that the product may have contained foreign material that was larger than the X-ray preventive control parameter. Therefore, it is not known if a corrective action is required.
Monitoring Records Verification
X-ray: As required by the preventive control the X-ray monitoring records were reviewed by the qualified individual. This verification revealed the daily checks were acceptable.
Supplier Control: The blackberries are purchased from two suppliers, supplier A and supplier B. Supplier B has a history of supplying blackberries that contain more rocks than supplier A. The food safety quality team confirmed the blackberries used during this production day were from supplier B.
From what we know so far in this scenario can we determine if a corrective action is required?
X-ray: This information led the team to believe that the higher level of product rejects were due to an unacceptable blackberry ingredient and not due to a failure of the X-ray system, which means the X-ray preventive control was adequately controlling the risk. As a precaution, the food safety and quality team want additional assurance that the blackberry cobbler finished product was acceptable, just in case the problem was with the X-ray equipment. The product was held and run through the separate calibrated X-ray. No additional rejects occurred. This confirmed that the X-ray process worked, and there is no need for a corrective action as related to the X-ray system.
Supplier: The blackberries were supplied by supplier B with a history of product that contained a higher level of rocks. We suggest that in this instance, a review of supplier B is definitely in order due to the higher amount of finished product found to contain foreign material, which is most likely blackberry briars.
Verification is one step to help ensure the food safety system is working to prevent, control or significantly reduce public health hazards. Verification includes validating the steps to ensure the process will work, and secondly includes the evaluation activities that verify the system continues to work. Verification activities are clearly defined in the FDA’s proposed Preventive Controls rule, as well as in current regulated HACCP requirements. This blackberry pie scenarios provided an example of how to apply the required verification steps as outlined in the FDA’s proposed Preventive Control rule.
For more details on verification, risks, and food safety solutions, read the entire White Paper written in cooperation with The Acheson Group: Verification: Can Your Food Safety Plan Meet the Rigors of FSMA’s Proposed Preventive Controls?